Duns Number:078352849
Device Description: D2S Fin Implant 4.5mm neck diameter, 4.5mm fin width and 16mm in length
Catalog Number
ID2S 4.5x16
Brand Name
TatumSurgical/D Implant
Version/Model Number
D2S - Fin/4.5x4.5x16
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 21, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K811923
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
e5ba9dd2-9934-419b-b934-15f9f5868a4a
Public Version Date
May 22, 2020
Public Version Number
4
DI Record Publish Date
October 30, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |